Advanced Course CTD module 3 - Quality section 2024
Schedule of Advanced Course CTD module 3 - Quality section 2024
| Day 1, Thursday, May 30 | |
| 8:30 - 9:00 | Registration & coffee |
| 9:00 - 9:15 | Welcome & Introduction to the course (Marc Benijts - Healixia) |
| 9:15 - 9:45 | Overview CTD – Quality related issues (Katrien Van Landuyt - FAMHP) |
| 9:45 - 10:30 | Stability in the Pharmaceutical World (Tine Eelen - Johnson & Johnson Innovative Medicine) |
| 10:30 - 10:45 | Coffee break |
| 10:45 - 11:30 | Drug substance: general requirements (Thomas Drapier - FAMHP) |
| 11:30 - 12:15 | Drug substance: synthesis and control during synthesis (Michel Guillaume - Auxilis) |
| 12:15 - 13:15 | Lunch break |
| 13:15 - 14:30 | Drug substance: impurities (Quality aspects: Eddy Dolusic - FAMHP; Non-clinical aspects: Evelyne Pirotte - FAMHP) |
| 14:30 - 15:15 | Drug products: General overview and practical tips (Isabelle Delneuville - FAMHP) |
| 15:15 - 15:30 | Coffee break |
| 15:30 - 16:15 | Solid oral dosage forms (Valérie Vanhoorne - UGent) |
| 16:15 - 17:00 | Parenteral dosage forms (Roland Schots - Roval Pharma) |
| Day 2, Friday, May 31 | |
| 9:00 - 9:45 | Variations according to Regulation EC 1234/2008 (Roselien Poppe - FAMHP) |
| 9:45 - 10:30 | Relevant analytical techniques and method validation (Evelien Wynendaele - UGent) |
| 10:30 - 11:00 | Coffee break |
| 11:00 - 11:45 | Handling of Variations to Module 3 (Eline Van der Biest & Liesbeth Bogaert - FAMHP) |
| 11:45 - 12:00 | Variations: Theoretical & practical application worked out through several case studies - Introduction to the cases (Mixed panel FAMHP & Industry) |
| 12:00 - 13:00 | Lunch break |
| 13:00 - 14:30 | Work out of case studies in workshops (1) (Mixed panel FAMHP & Industry) |
| 14:30 - 15:30 | Work out of case studies in workshops (2) (Mixed panel FAMHP & Industry) |
| 15:30 - 15:45 | Coffee break |
| 15:45 - 17:15 | Work out of case studies in workshops (3) (Mixed panel FAMHP & Industry) |
| 17:15 - 17:30 | Closing Remarks (Marc Benijts - Healixia) |